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NCT Number: NCT07417969

"Effect of Albumin Combined With Furosemide in Critically Ill Patients With Fluid Overload: Impact on Urine Output and Renal Function"

This study aims to compare the effectiveness of furosemide alone versus the combination of furosemide plus albumin in critically ill adult patients with fluid overload. The trial evaluates whether co-administration of albumin enhances diuretic response compared with standard furosemide therapy. The primary outcomes include urine output at 2 hours, changes in renal perfusion markers, and biochemical parameters. Secondary outcomes include changes in mean arterial pressure, electrolyte balance, and renal resistance index. The study seeks to determine whether adding albumin provides a clinically meaningful improvement in diuresis and renal function compared with furosemide monotherapy.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

76000

Querétaro City, Querétaro, 26089, Mexico

Location status: Recruiting

Location contact

Alina Elizabeth Arechiga Casas, MD

CONTACT

[email protected]

+52 8781360564

About this study

This randomized clinical study evaluates two diuretic strategies for fluid overload in adult critically ill patients: furosemide monotherapy versus combined therapy with furosemide plus albumin. Albumin may enhance diuretic effectiveness by increasing intravascular oncotic pressure, improving renal perfusion, and facilitating drug delivery to the nephron.

The protocol includes standardized dosing, measurement of urine output at 2 hours, and analysis of serum and urine biochemical parameters. Bedside ultrasound will be used to assess markers of fluid overload, including evaluation of the inferior vena cava and venous congestion patterns. Hemodynamic variables, electrolyte changes, and estimated glomerular filtration rate will also be monitored.

The study aims to determine whether the co-administration of albumin provides a clinically meaningful improvement in diuretic response and renal function compared with furosemide monotherapy in critically ill patients with fluid overload.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 years
  • Critically ill patients admitted to the intensive care unit (ICU)
  • Presence of oliguria defined as urine output <0.5 mL/kg/hour for at least 6 hours

Exclusion criteria

  • Refusal to participate by the patient or legal representative
  • Patients receiving palliative or end-of-life care
  • Acute or chronic kidney failure requiring ongoing renal replacement therapy at enrollment
  • Chronic dialysis dependency
  • Participation in another interventional clinical trial
  • Pregnant or lactating women

Treatment and study plan

Furosemide plus albumin

Drug

Furosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes.

Furosemide (Diuretic)

Drug

Furosemide 1 mg/kg IV as a single dose, infused over 30 minutes, plus placebo (normal saline).

Primary outcomes

  1. Urine output (mL) at 2 hours after administration of the assigned treatment

    Time frame: 2 hours after administration of the study treatment.

    Total urine output measured in milliliters within the first 2 hours after administration of the assigned treatment (furosemide alone or furosemide plus albumin), using a urinary catheter and standard collection methods.

Secondary outcomes

  1. Change in inferior vena cava (IVC) diameter and venous congestion patterns at 2 hours

    Time frame: baseline to 2 hours

    Change in inferior vena cava (IVC) diameter (mm) and venous congestion patterns assessed by bedside ultrasound from baseline to 2 hours after treatment administration.

  2. Change in Serum Potassium Concentration

    Time frame: 24 hours

    Change in serum potassium concentration from baseline to 24 hours after administration of the assigned treatment.

  3. Change in Serum Creatinine

    Time frame: Baseline to 24 hours.

    Change in serum creatinine from baseline to 24 hours after administration of the assigned treatment.

  4. Change in Serum Sodium Concentration

    Time frame: 24 hours

    Change in serum sodium concentration from baseline to 24 hours after administration of the assigned treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Alina Elizabeth Arechiga Casas, MD

CONTACT

[email protected]

+52 8781360564

Sponsors and collaborators

Lead sponsor

Jose J Zaragoza, MD MSc

Other

Registry information

Official study title

"Comparison of Furosemide Versus Albumin Plus Furosemide in Increasing Urine Output in Critically Ill Patients: A Double-Blind Randomized Clinical Trial"

Acronym: FANTASTIC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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